Bendel Insurance House, 19 Tinubu Street, 7th Floor, Marina, Lagos
Tel: +234-803-445-7836; 803-305-8898
Branch of OPC Pharmaceutical Joint-Stock Company at Binh Duong – OPC Pharmaceutical Factory
Head office: 1017 Hong Bang Street, ward 12, District 6, Ho Chi Minh city, Vietnam.
Place of business: Tan Hoa Hamlet, Tan Vinh Hiep, Tan Uyen District, Binh Duong Province, Vietna.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Caplet (NRN: A4-3804): Dihydroartemisinin 40 mg, Piperaquine Phosphate 320 mg. Excipients q.s.f 1 caplet
Pack Size: Amnoquine Caplet 40 mg+320 mg is available in a pack of 9’s.
Amnoquine is a fixed-dose combination of Dihydroartemisinin and Piperaquine Phosphate to treat multi-resistant Plasmodium falciparum malaria. Piperaquine Phosphate is a 4-piperazinoquinoline derivative with a relatively long half-life compared to other partner drugs within current Artemisinin-based Combination Therapies (ACTs). As a result, the combination thereby is effective both in treating clinical malaria and in providing longer, protection from re-infection than other ACTs.
Mechanism of Action:
Dihydroartemisinin mainly interferes with the membrane structures of trophozoites (erythrocytic asexual forms) i.e. whorled food vacuole membrane, distended mitochondria, swollen nuclear membranes, dissociation of ribosomes from endoplasmic reticulum leading to cytoplasmic vacuolization and autophagocytosis. In addition, biochemical depression of protein synthesis and nucleic acid synthesis are exhibited.
Piperaquine Phosphate interferes with physiological function of the food vacuole membrane of the trophozoites leading to autophagocytosis of the parasites. It has no marked effect on the ring worms, immature or mature schizonts and the male or female gametocytes.
The two active ingredients of Dihydroartemisinin+Piperaquine Phosphate have synergistic effect.
Upon oral administration, Dihydroartemisinin is rapidly absorbed and maximum blood concentration is attained 1 hour afterwards, with a half life of about 4 hours. It is widely distributed in the body but with more concentration in liver, bile and kidneys. Approximately 80% is excreted through the Urine and faeces within 24 hours after administration. Upon oral administration of Piperaquine Phosphate, about 80–90% is absorbed within 24 hours.
It is widely distributed in the body mainly in the liver, kidneys, lungs and spleen. About 25% of total dose is partitioned in liver within 8 hours of intake. Elimination is very slow with a half life of 9.4 days. It is excreted through bile by hepatoenteral circulation.
Amnoquine is indicated for treatment of all kinds of malaria, even malaria caused by multi resistant Plasmodium falciparum
Patients with hypersensitivity to its compounds. Infants under 6 months or below 7 kg in weight.
WARNINGS AND PRECAUTIONS:
People who are taking or has taken any other medicines that increase plasma-piperaquine concentration; Children who are vomiting, females, the elderly (over 65 years); Women during pregnancy or breastfeeding; Patients with liver or kidney problems;
PREGNANCY AND BREAST-FEEDING:
Amnoquine must not be used in pregnancy if there is an alternative medicine. Avoid breast-feeding while taking Amnoquine.
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breast-feeding.
DRIVING AND USING MACHINES: People can drive or use machines after taking Amnoquine.
QT prolongation can occur and can cause arrhythmias. Obtain ECG as soon as possible after starting treatment then continue monitoring in those taking or has taken any other medicines that increase plasma-piperaquine concentration, in children who are vomiting, in females, or in the elderly; consider obtaining ECG in all patients before third dose and 4–6 hours after third dose; if QTC interval more than 500 milliseconds, discontinue treatment and monitor ECG for a further 24–48 hours. In case of suspected overdosage, symptomatic specialized therapy should be given without any delay.
Contact your doctor as soon as possible when notice palpitations or irregular heart beat
Avoid concomitant use Amnoquine with: Analgesics (methadone), Anti-arrhythmics (amiodarone and disopyramide), Antibacterials (macrolides, moxifloxacin), Antidepressants (citalopram and escitalopram), Antifungals (imidazoles and triazoles), Antihistamines (mizolastine), Antipsychotics (droperidol, haloperidol, phenothiazines and pimozide), Antivirals (saquinavir), Beta-blockers (sotatol), Cytotoxics (arsenic trioxide), domperidone, pentamidine isetionate : due to the possible risk of ventricular arrhythmias
Also avoid concomitant use Amnoquine with: rifampicin, other Antidepressants, Antiepileptics (carbamazepine, phenobarbital and phenytoin), Antimalarials (artemether with lumefantrine), Cytotoxics (vinblastine, vincristine, vinflunine and vinorelbine), grapefruit juice, histamine.
Antimalarias inactivate oral typhoid.
Note: Piperaquine has a long half-life; there is a potential for drug interactions to occur for up to 3 months after treatment has been stopped.
QT interval prolonged, tachycardia, headache, malaise, anaemia; less commonly nausea, vomiting, abdominal pain, diarrhea.
Consult your doctor if any side effect occurs.
Dosage & Administration
DOSAGE AND ADMINISTRATION:
A course of Amnoquine lasts 3 consecutive days. Take one dose on each day. Caplets should be taken at about the same time on each of three days. Amnoquine should be taken oral with water at least 3 hours before or 3 hours after food. Caplets may be crushed and mixed with water immediately before administration.
Dosage for adult and child over 6 months:
|Body-weight||Daily dose (caplet)|
|7 – 13 kg||1/2 caplet once daily for 3 days|
|13 – 24 kg||1 caplet once daily for 3 days|
|24 – 36 kg||2 caplets once daily for 3 days|
|36 – 75 kg||3 caplets once daily for 3 days|
|75 – 100 kg||4 caplets once daily for 3 days|
Body weight more than 100 kg, follows the dose that doctor has prescribed.
If a patient vomits within 30 minutes of taking Amnoquine, the whole dose should be re-administered; if a patient vomits within 30-60 minutes, half the dose should be re-administered. Re-dosing with Amnoquine should not be attempted more than once. If a dose is missed, it should be taken as soon as realised and then the recommended regimen is continued until the full course of treatment has been completed. In case the dose missed is the second dose, the third dose should be taken approximately 24 hours after the second dose.
A new course of Amnoquine should not be taken within four weeks after the first treatment, due to the long elimination half-life of piperaquine.
Do not store above 30°C. Store in the original package in order to protect from light and moisture.
SHELF–LIFE: 36 months from manufacturing date.